Device product
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Z-1032-2017
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 75989
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98
- Official record key
device-enforcement:Z-1032-2017
Official wording
Reason: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Code information: Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776
Distribution pattern: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Derived failure modes
-
Unknown
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.